Blood-Flow Restriction Exercise Following a Knee Replacement

Study Purpose

This study will determine the safety and efficacy of using blood-flow restriction exercise enhancement (B-FREE) to overcome persistent quadriceps muscle weakness that occurs following a total knee replacement (TKR).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 40 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria.

  • - 40-75 years of age.
  • - Have had a unilateral TKA > 6 months prior to participation (Arm 1) - No previous history of knee injury/surgery (Arm 2) Exclusion Criteria.
  • - Are a smoker.
  • - Have diabetes.
  • - Have suffered a heart attack or stroke.
  • - Have any cardiopulmonary disorders (hypertension discussed below) - Have been diagnosed with any neurological disorders.
  • - Have any implanted devices such as but not limited to a pacemaker or pain pump.
- Uncontrolled (not medicated) Stage 1 hypertension or Stage 2 hypertension

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04018638
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Michigan Technological University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steven Elmer
Principal Investigator Affiliation Michigan Technological University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Knee Injuries, Knee Osteoarthritis, Knee Arthritis
Additional Details

This study aims to determine the safety and efficacy of using B-FREE to overcome persistent quadriceps muscle weakness that occurs following a TKR. We hypothesize that B-FREE can provide a safe training stimulus and offer a home-based program to restore quadriceps muscle strength and improve functional mobility. Specifically, subjects that have a TKR will perform B-FREE at home (light weights with resistance bands and walking) 3x/wk for 10 weeks. Quadriceps muscle strength, balance, and functional mobility will be assessed before and after the program. Changes in these variables will be compared to healthy age-matched uninjured controls.

Arms & Interventions

Arms

Experimental: Adults with TKR Perform Home Exercise Program

Participants that have a total knee replacement will complete a home-based exercise program

No Intervention: Healthy Controls Only

Participants that have no history of knee joint dysfunction will serve as age-matched uninjured controls

Interventions

Other: - B-FREE

Blood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Michigan Technological University, Houghton, Michigan

Status

Recruiting

Address

Michigan Technological University

Houghton, Michigan, 49931

Site Contact

Director, Human Research Protections

[email protected]

906-487-2902